A Pilot Feasibility Study to Evaluate the Efficacy of Lapatinib in Eliminating Cytokeratin-positive Tumour Cells Circulating in the Blood of Women With Breast Cancer

Trial Information

A Pilot Feasibility Study to Evaluate the Efficacy of Lapatinib in Eliminating Cytokeratin-positive Tumour Cells Circulating in the Blood of Women With Breast Cancer

Breast cancer is considered a systemic disease since early tumour cell dissemination may
occur even in patients with small tumours; several investigators using immunocytochemistry
or real time PCR (RT-PCR) have shown that cytokeratin-positive epithelial cells could be
identified in the bone marrow aspirates or the peripheral blood of otherwise metastases-free
patients with stage I and II breast cancer. The clinical importance of the
immunocytochemical detection of occult tumour cells in the bone marrow has been confirmed in
many prospective studies to represent an independent predictive and prognostic factor for
distant relapse and reduced survival.

Patients with metastatic breast cancer who have persistent detection of tumour cells in the
peripheral blood (≥5 cells/7.5 ml) despite at least one line of chemotherapy will receive
lapatinib for a minimum of one month unless disease progression occurs at an earlier time
point.

- Evidence of any other disease, neurological or metabolic dysfunction, physical
examination finding or laboratory finding giving reasonable suspicion of a disease or
condition that contraindicates the use of an investigational drug or puts the patient
at high risk for treatment-related complications

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